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Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy

Primary Purpose

Office Hysteroscopy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
warming saline media
room temperature saline media
Sponsored by
Amira Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Office Hysteroscopy focused on measuring warm saline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • - Age ≥ 18 years old.
  • Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies.

Exclusion Criteria:

  • - Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure.
  • Any usage of analgesic agent on the day of the procedure.
  • Failure of entry of the cervical canal requiring cervical dilatation.
  • Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
  • Patient refusal to participate in the study.

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

warm saline

room temperature saline

Arm Description

Patients who used warm saline as a distention media in office hysteroscopy

Patients who used room temprature saline as a distention media in office hysteroscopy

Outcomes

Primary Outcome Measures

warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)
The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)

Secondary Outcome Measures

The clarity of the view.(questionnaire).
questionnaire including clear (better outcome) or dim (worse out come)

Full Information

First Posted
January 12, 2022
Last Updated
February 17, 2022
Sponsor
Amira Mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT05246436
Brief Title
Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy
Official Title
Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy: Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amira Mohamed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure. Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office hysteroscopy. Research question: In women undergoing office hysteroscopy, Will there be a difference in pain perceived during the procedure if the investigators use warm saline(body temperature 37°C) rather than normal saline (room temperature) as a distension media?
Detailed Description
Office hysteroscopy is a procedure where a doctor uses a thin tube with a tiny camera to look inside the uterus. There are no incisions. Saline solution is used to expand the uterus in order to look at the inside of the uterus . The vaginoscopic 'non-touch' technique first described by Bettocchi and Selvaggi (1997) has avoided the need for using a speculum and tenaculum in outpatient hysteroscopy; miniaturization of fibreoptic instruments has also enabled the procedure to be conducted without intra- or paracervical anesthesia. Indications for diagnostic & therapeutic outpatient hysteroscopy include abnormal uterine bleeding, reproductive problems, glandular abnormalities on cervical smear, identification and retrieval of lost intrauterine devices, polypectomy, endometrial ablation and myomectomy. Hysteroscopic procedures can be successfully performed in an office setting without any anesthesia. There are pharmacological and non pharmacological analgesic methods. Non pharmacological methods, such as vaginoscopy or mini hysteroscopes, are advisable to avoid producing pain . The pharmacological method including intervention method which is para cervical block, reducing pain during and 30 minutes after hysteroscopy. And medical methods such as Non steroidal anti-inflammatory drugs (NSAIDs) seem to be useful in the postoperative period. Evidence is not clear about combination of techniques or misoprostol . Endometrial cavity is an empty cavity and requires distension to permit visualization. Therefore, during hysteroscopy either fluid or carbon dioxide gas is used to enlarge the endometrial cavity. To achieve a panoramic view, the uterine walls must be forcibly separated. The thick muscle of uterine walls needs a minimum pressure of 40 mm Hg to distend the cavity adequately for hysteroscopic visualization. Normal saline is usually recommended as the distention medium in outpatient hysteroscopy as it allows improved image resolution and is associated with less vasovagal episodes compared with carbon dioxide. Although it is thought that uterine contractility could be provoked by instillation of saline at lower temperatures, there is little data on the effect of temperature on clarity of image, discomfort/pain, outcome of the procedure and patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Office Hysteroscopy
Keywords
warm saline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warm saline
Arm Type
Active Comparator
Arm Description
Patients who used warm saline as a distention media in office hysteroscopy
Arm Title
room temperature saline
Arm Type
Sham Comparator
Arm Description
Patients who used room temprature saline as a distention media in office hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
warming saline media
Intervention Description
use warm saline as a distention media in office hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
room temperature saline media
Intervention Description
use room temperature saline as a distention media in office hysteroscopy
Primary Outcome Measure Information:
Title
warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)
Description
The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)
Time Frame
base line
Secondary Outcome Measure Information:
Title
The clarity of the view.(questionnaire).
Description
questionnaire including clear (better outcome) or dim (worse out come)
Time Frame
base line
Other Pre-specified Outcome Measures:
Title
The ease of entry of the hysteroscopy.(questionnaire)
Description
questionnaire including easy (better out come) difficult (worse out come)
Time Frame
base line
Title
Patient satisfaction.(questionnaire)
Description
questionnaire including yes (better outcome ) No (worse outcome)
Time Frame
base line
Title
Time of the procedure.(time by minutes)
Description
calculate time of each procedure by minutes
Time Frame
base line
Title
complications (questionnaire)
Description
questionnaire including No complications ( better outcome ) complications happen (worse outcome)
Time Frame
base line

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Age ≥ 18 years old. Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies. Exclusion Criteria: - Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure. Any usage of analgesic agent on the day of the procedure. Failure of entry of the cervical canal requiring cervical dilatation. Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis. Patient refusal to participate in the study.
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
29949273
Citation
Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.
Results Reference
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Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy

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